drugset / Trial / NCT07864896

Suzetrigine in TKA

NCT07864896 ↗

Phase 3 Recruiting 148 enrolled Hospital for Special Surgery, New York
RandomizedParallel-groupTriple-blindTreatment

Summary

Total knee replacements are among the most common and painful orthopedic procedures performed worldwide, often requiring intensive analgesia to support early ambulation and recovery. Despite widespread use of multimodal regimens, many patients still rely on opioids, which can cause sedation, nausea, constipation, and long-term dependency. Evaluating suzetrigine in this high-need population may improve recovery trajectories, reduce opioid consumption, and support enhanced recovery protocols. Given the growing surgical volume and the emphasis on opioid-sparing strategies, rigorous investigation of suzetrigine's efficacy in total knee replacement is of high clinical value. In this confirmatory (phase III) trial, patients undergoing primary total knee replacement will be randomized to receive either suzetrigine or placebo for 2 weeks (14 days), with the loading dose administered prior to surgery. The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU).

Timeline

Start
2026-10-07
Primary completion
2029-01
Completion
2030-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Suzetrigine Small molecule — —

Indications

No indication recorded.